U.S. patent application number 10/506909 was filed with the patent office on 2005-06-02 for medicament delivery and packaging.
Invention is credited to Chawla, Brindra Paul Singh.
Application Number | 20050115562 10/506909 |
Document ID | / |
Family ID | 9932642 |
Filed Date | 2005-06-02 |
United States Patent
Application |
20050115562 |
Kind Code |
A1 |
Chawla, Brindra Paul Singh |
June 2, 2005 |
Medicament delivery and packaging
Abstract
A system is disclosed for the administration of a powdered
medicament by inhalation. The system comprises a container (20, 60,
120) containing a unit dose of medicament in powder form, the
container (20, 60, 120) having at least one dispensing aperture
(21), and a device (10, 50, 100) having a chamber (19, 56, 110)
adapted to receive said container (20, 60, 120). The device (10,
50, 100) further comprises air inlet means (12, 12a, 13, 13a, 112,
113) by which air may be drawn into the chamber (19, 56, 110) and
means (11, 111) by which air and entrained medicament may be drawn
out of the chamber (19, 56, 110). The system is arranged such that
the container (20, 60, 120), in use, is stationary within the
chamber (19, 56, 110).
Inventors: |
Chawla, Brindra Paul Singh;
(Nottingham, GB) |
Correspondence
Address: |
Woodling Krast and Rust
9213 Chillicothe Road
Kirtland
OH
44094
US
|
Family ID: |
9932642 |
Appl. No.: |
10/506909 |
Filed: |
September 8, 2004 |
PCT Filed: |
March 10, 2003 |
PCT NO: |
PCT/GB03/01004 |
Current U.S.
Class: |
128/203.15 |
Current CPC
Class: |
A61M 15/0043 20140204;
A61M 2202/064 20130101; A61M 15/0028 20130101; A61M 2206/16
20130101 |
Class at
Publication: |
128/203.15 |
International
Class: |
B05D 007/14; A61M
015/00; A61M 016/00 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 9, 2002 |
GB |
0205572.1 |
Claims
1. A system for the administration of a powdered medicament by
inhalation, the system comprising a container containing a unit
dose of medicament in powder form, the container having at least
one dispensing aperture, and a device having a chamber adapted to
receive said container, the device further comprising air inlet
means by which air may be drawn into the chamber and means by which
air and entrained medicament may be drawn out of the chamber,
wherein a part of the wall of the chamber is formed as a deformable
enclosure within which the container is received such that the at
least one dispensing aperture is sealed and from which the
container can be introduced into the chamber by pressure applied to
the external surface of the deformable enclosure, the system being
arranged such that when the container is introduced into the
chamber the container is held stationary.
2. A system as claimed in claim 1, wherein the system comprises a
device and a plurality of medicament containers.
3. A system as claimed in claim 1, wherein the container is
physically attached to the enclosure.
4. A system as claimed in claim 3, wherein the container is formed
with a projection that extends through an opening in the
enclosure.
5. A system as claimed in claim 3, wherein the container is bonded
to the enclosure.
6. A system as claimed in claim 1, wherein the container and/or the
chamber are provided with formations that are effective in holding
the container in a stationary position once the container has been
introduced into the chamber.
7. A system as claimed in claim 1, wherein the container is held
stationary by virtue of being captivated between opposing parts of
the chamber after being released from the enclosure.
8. A system as claimed in claim 1, wherein the means by which air
and entrained medicament are withdrawn from the chamber comprises
one or more apertures formed in a wall of the chamber.
9. A system as claimed in claim 8, wherein the apertures and the
air inlet means are sealed prior to use by a removable sealing
membrane.
10. A system as claimed in claim 1, wherein the enclosure and
container from a medicament package which may be removed from the
delivery device.
11. A system as claimed in claim 10, wherein the medicament package
comprises a rigid support to which the enclosure is bonded, and the
device is provided with receiving means with which the rigid
support can be engaged.
12. A system as claimed in claim 1, wherein the chamber is circular
in form.
13. A system as claimed in claim 12, wherein the air inlet means
are arranged such that air enters the chamber substantially
tangentially so as to facilitate the emptying of the container.
14. A system as claimed in claim 1, wherein the device is provided
with a plurality of air inlets opening into the chamber at
substantially equiangularly spaced positions.
15. A system as claimed in claim 1, wherein the medicament
container is cylindrical.
16. A system as claimed in claim 15, wherein the diameter of the
cylinder is comparable to or greater than its depth.
17. A system as claimed in claim 16, wherein the depth of the
cylinder is equal to or less than its diameter.
18. A system as claimed in claim 1, wherein the medicament
container is provided with a plurality of dispensing apertures.
19. A system as claimed in claim 1, wherein the enclosure is of
elastomeric material.
20. A system as claimed in claim 1, wherein the medicament
container is of plastics material.
Description
[0001] This invention relates to delivery devices and packaging for
medicaments, in particular to delivery devices and packaging for
the administration of medicaments by inhalation.
[0002] The most common methods of administering powdered medicament
by inhalation are pressurised aerosol inhalers and dry powder
inhalers. Conventional dry powder inhalers use medicament packaged
in a gelatine capsule. An improved method of administration,
however, is disclosed in WO 98/26828.
[0003] WO 98/26828 discloses several delivery devices for use with
medicament containers that contain pre-formed openings through
which medicament is dispensed within the delivery device. The
delivery devices all comprise a mouthpiece, air inlet means and a
chamber in which the medicament container is located. In use, air
is drawn into the chamber causing the medicament container to
follow an orbital path around the chamber. In this way the
medicament is dispensed through the openings of the medicament
container and medicament entrained with air is drawn out of the
chamber and through the mouthpiece. The disclosed delivery devices
include single-use delivery devices pre-loaded with a medicament
container and multi-use delivery devices in which a medicament
container is inserted into the chamber before use.
[0004] The delivery devices and medicament packages disclosed in WO
98/26828 represent a considerable advance over the prior art, but
are nonetheless susceptible to further improvement. In particular,
the movement of the medicament container may, in use, be audible,
which may be undesirable in certain situations.
[0005] There has now been devised an improved form of medicament
delivery device and medicament packaging that overcomes or
substantially mitigates the above-mentioned and/or other
disadvantages of the prior art. In particular, it has surprisingly
been found that a medicament container of the general type
disclosed in WO 98/26828 may be caused to empty satisfactorily
without undergoing movement.
[0006] According to the invention, there is provided a system for
the administration of a powdered medicament by inhalation, the
system comprising a container containing a unit dose of medicament
in powder form, the container having at least one dispensing
aperture, and a device having a chamber adapted to receive said
container, the device further comprising air inlet means by which
air may be drawn into the chamber and means by which air and
entrained medicament may be drawn out of the chamber, wherein the
system is arranged such that the container, in use, is stationary
within the chamber.
[0007] The system according to the invention is advantageous
primarily in that the medicament container empties without
undergoing movement. As a result, the noise generated in use is
low. Because the container does not need to undergo motion brought
about by the airflow in the device, the required airflow in the
device is relatively low, leading to greater ease of use, eg by
users with impaired lung function.
[0008] It will be appreciated that inhalation of the medicament may
be oral inhalation, or nasal inhalation. In either case, the device
may be appropriately formed for the desired mode of administration.
For example, the device may be formed with a mouthpiece or the like
to facilitate inhalation. Likewise, for nasal inhalation, the
device may be formed with an extension adapted to be offered up to,
or inserted into, the user's nostril.
[0009] The device may be configured for single or repeated use. In
either case, the device is preferably provided with means for
storing the container, whilst sealing the at least one aperture,
means for introducing the container into the chamber, and means for
holding the container stationary within the chamber.
[0010] It will be appreciated that the system according to the
invention may comprise a device and a single container, or a device
and a plurality of containers. In the latter case, the plurality of
containers may each contain the same medicament, or the containers
may contain doses of two or more different medicaments, for
simultaneous or sequential administration.
[0011] Where the system comprises a plurality of containers, those
containers may be held in a magazine or cartridge that is coupled
with the device to enable each container to be introduced
sequentially into the chamber. For instance, the cartridge may take
the form of a rotatable disk, suitable mechanical means being
provided for indexing of the cartridge so as to bring the
containers into registration with the chamber.
[0012] Preferably, the means for storing the container and
introducing the container into the chamber take the form of an
enclosure of deformable material arranged such that manual pressure
introduces the container into the chamber.
[0013] According to another, more specific, aspect of the
invention, there is provided a system for the administration of a
powdered medicament by inhalation, the system comprising a
container containing a unit dose of medicament in powder form, the
container having at least one dispensing aperture, and a device
having a chamber adapted to receive said container, the device
further comprising air inlet means by which air may be drawn into
the chamber and means by which air and entrained medicament may be
drawn out of the chamber, wherein a part of the wall of the chamber
is formed as a deformable enclosure within which the container is
received such that the at least one dispensing aperture is sealed
and from which the container can be introduced into the chamber by
pressure applied to the external surface of the deformable
enclosure, the system being arranged such that when the container
is introduced into the chamber, the container is held
stationary.
[0014] The container may be held stationary within the chamber by
any suitable means. For instance, the container may be physically
attached to the enclosure, such that when the enclosure is deformed
and the container thereby introduced into the chamber the
attachment of the container to the enclosure prevents movement of
the container within the chamber. Alternatively, the container
and/or the chamber may be provided with formations that are
effective in holding the container in a stationary position once
the container has been introduced into the chamber. For instance,
the chamber may be provided with a recess in which the container is
received when introduced into the chamber. Alternatively, the wall
of the chamber that faces the enclosure may be provided with one or
more projections that engage the container when the container is
introduced into the chamber. In a further alternative, the
container may be provided with one or more locating formations that
engage with corresponding formations provided in the chamber. For
instance, the container may be provided with a projecting lug that
engages in a recess or opening formed in the wall of the chamber
opposite to the enclosure. In a further alternative, there may be
no physical attachment between the container and the chamber, but
the dimensions of the container may be such that, when introduced
into the chamber from the enclosure, it is simply captivated
between opposing parts of the chamber, eg the base of the chamber
and the periphery of the enclosure.
[0015] Where the container is physically attached to the enclosure,
this may be by means of a projection formed on the container that
extends through an opening in the enclosure. Such a projection may
take the form of a stud, preferably formed integrally with the
container, that projects through an opening in the enclosure and
has an enlarged upper portion. Alternatively, the container may be
bonded to the enclosure. Such bonding may be brought about by the
application of heat and/or pressure, or alternatively by the use of
adhesive.
[0016] In the case of a device intended for single use and then
disposal, the means by which air and entrained medicament are drawn
out of the chamber may simply comprise one or more apertures formed
in a wall of the chamber. Preferably, these apertures and the air
inlet means are sealed prior to use. Such a seal is most
conveniently achieved by the provision of a removable sealing
membrane, eg in the form of a laminated plastics sheet which is
fixed in place by a suitable adhesive. The sealing membrane is
preferably provided with a projecting portion or tab by which it
can be grasped for ease of removal.
[0017] In the case of a device intended for repeated use, the
enclosure and container may form a medicament package which may be
attached to, and removed from, the delivery device. In such a case
the medicament package preferably comprises a rigid support to
which the enclosure is bonded, and the device is preferably
provided with receiving means with which the rigid support can be
engaged. Such receiving means may take the form of grooved
formations with which the rigid support can be engaged. The
receiving means are preferably provided adjacent an opening in the
device such that engagement of the medicament package with the
receiving means closes the opening.
[0018] The chamber is preferably circular in form. In some
embodiments, the air inlet means are preferably arranged such that
air enters the chamber substantially tangentially so as to
facilitate the emptying of the container. There may be provided a
plurality of air inlets, which may, but do not necessarily, open
into the chamber at substantially equiangularly spaced
positions.
[0019] The medicament container may have any shape. However, the
container is preferably cylindrical or substantially cylindrical.
In some embodiments, the diameter of the cylinder is typically
comparable to or greater than its depth. For example, the depth of
the cylinder may be no more than 1.5 times the diameter of the
cylinder, and more preferably is equal to or less than the
diameter. The container thus preferably has the form of a drum.
[0020] The medicament container is preferably provided with a
plurality of dispensing apertures. In the case of a cylindrical
container, the dispensing apertures are preferably disposed
equiangularly around the cylindrical periphery of the
container.
[0021] The device may be manufactured from materials conventionally
utilised in inhalation drug delivery devices. For reasons of cost
and manufacturing convenience, the device is most preferably
manufactured by injection moulding in plastics material. Examples
of suitable plastics materials include polycarbonate, polypropylene
and polyethylene. Metals may also be used to form all or part of
the device. Examples of suitable metals include aluminium and
stainless steel. The device may be formed as a single
injection-moulded component, or it may comprise a plurality of
components that are subsequently bonded or otherwise connected
together.
[0022] The enclosure is most preferably formed in deformable
plastics material. The enclosure may be formed in the same material
as the device, the necessary deformability being created if
necessary by the use of material of reduced thickness.
Alternatively, the enclosure may be formed in elastomeric material,
most preferably a medical grade thermoplastic rubber. In such a
case, the enclosure may be formed, together with the rest of the
device (or the part of the device to which the enclosure is
attached), or with the rigid support that together with the
enclosure makes up a medicament package, by a two-shot moulding
operation in which a first moulding is made in a relatively rigid
plastics material and the elastomeric material is then moulded onto
the first moulding.
[0023] The medicament container is preferably of a material which
is substantially impermeable to moisture. The container is
preferably of plastics material, most preferably polypropylene. The
container may comprise two or more cooperating components that
together define the container. Most preferably, the container is
formed in two parts that fit together with a snap-fit or the like,
one or both parts having formations that define the at least one
dispensing aperture at the junction of the two parts. The two or
more cooperating parts are preferably manufactured by injection
moulding. As an alternative to the use of plastics materials, one
or more parts of the container may be formed in metal, eg by
pressing from a suitable sheet of metal. Metals that may be used
include aluminium.
[0024] The invention will now be described in greater detail, by
way of illustration only, with reference to the accompanying
drawings, in which
[0025] FIG. 1 is a plan view of a first embodiment of a powdered
medicament inhaler according to the invention;
[0026] FIG. 2 is a side view of a medicament container that forms
part of the inhaler of FIG. 1;
[0027] FIG. 3 is a sectional view along line III-III of FIG. 1;
[0028] FIG. 4 is a sectional view along line IV-IV of FIG. 3;
[0029] FIG. 5 is a sectional view, along line III-III of FIG. 1, of
the inhaler in use;
[0030] FIG. 6 is a plan view of a second embodiment of a powdered
medicament inhaler according to the invention;
[0031] FIG. 7 is a sectional view along line VII-VII of FIG. 6;
[0032] FIG. 8 is a side view of a medicament package according to
the invention;
[0033] FIG. 9 is a view similar to that of FIG. 7, of the inhaler
engaged with a medicament package;
[0034] FIG. 10 is a view similar to that of FIG. 9, of the inhaler
in use;
[0035] FIG. 11 is a front view of a third embodiment of a powdered
medicament inhaler according to the invention;
[0036] FIG. 12 is a rear view of the inhaler of FIG. 11;
[0037] FIG. 13 is a sectional view along the line XIII-XIII of FIG.
11;
[0038] FIG. 14 is a view similar to that of FIG. 13 of the inhaler
during use; and
[0039] FIG. 15 is a plan view of a further embodiment of an inhaler
according to the invention, adapted for nasal inhalation.
[0040] Referring first to FIGS. 1 and 2, a first embodiment of a
medicament inhaler according to the invention is generally
designated 10. The inhaler 10 comprises a main body 18, an
enclosure 14 and a medicament container 20. The main body 18 and
the medicament container 20 are both moulded in plastics material,
whilst the enclosure 14 is of elastomeric material. In the
drawings, the main body 18 is shown as a unitary component, but in
practice it may be necessary or desirable for the main body 18 to
be formed as two or more separate components that are assembled
together in a subsequent fabrication step.
[0041] Referring to FIG. 2, the container 20 is formed from two
interlocking components 20a and 20b, each of which is
injection-moulded in plastics material, such that the container 20
has a cylindrical lower part and an upper part of generally domed
or conical shape. The abutting edges of the two components 20a, 20b
are formed so as to define a series of equiangularly spaced
apertures 21. At the apex of the upper part of the container, the
container 20 is formed with an integral stud 22 having an enlarged
upper portion.
[0042] Referring to FIGS. 1, 3 and 4, the main body 18 comprises a
mouthpiece 11, a passageway 16, a chamber 19, conduits 12a, 13a and
air inlets 12, 13. The mouthpiece is a generally elliptical opening
in one end of the main body 18. The passageway extends from the
mouthpiece 11 and through the lower part of the main body 18. The
chamber 19 is cylindrical in shape and is positioned above the
passageway 16. The chamber 19 communicates with the passageway 16
by means of a series of openings which make up a generally circular
grid 15 in the centre of the base of the chamber 19, as shown in
FIG. 4.
[0043] There are two front air inlets 12 and two rear air inlets 13
which connect the wall of the chamber 19 and the exterior of the
inhaler 10 by means of respective conduits 12a, 13a, as shown in
FIG. 4. The conduits 12a, 13a are aligned substantially
tangentially to the wall of the chamber 19 and connect to the
chamber 19 at equiangularly spaced locations.
[0044] Referring now to FIG. 3, the upper wall of the chamber 19
includes a circular aperture 17. The interior wall of the circular
aperture 17 is bonded to the enclosure 14, the enclosure 14
extending above the chamber 19. The enclosure 14 is of similar
shape to the container 20 save that the enclosure 14 has an open
lower end and a circular aperture at its apex. The enclosure 14 is
dimensioned such that the container 20 is closely received within
the enclosure 14 with an interference fit and the stud 22 is
pressed through the aperture of the enclosure 14, thereby holding
the container 20 within the enclosure 14. The aperture of the
enclosure 14 is dimensioned such that the lower portion of the stud
fits closely within the aperture of the enclosure 14. The inhaler
10 is shown in FIG. 3 prior to use, with the medicament sealed
within the container 10.
[0045] When the patient is ready to use the inhaler 10, the patient
applies downward finger pressure on the enclosure 14 such that the
enclosure 14 is turned inside out and extends partially into the
chamber 19. The stud 22 projecting through the aperture of the
enclosure 14 remains in this position thereby holding the container
20 in the centre of the chamber 19, as shown in FIG. 5.
[0046] The patient then places the mouthpiece 11 to their mouth and
inhales. Air is drawn through the air inlets 12, 13, along the
conduits 12a, 13a and substantially tangentially into the chamber
19. The airstream passes through the grid 15 and along the
passageway 16 to the patients mouth. The stream of air entering the
chamber 19 causes the medicament to be dispensed from within the
medicament container 20, through the apertures 21 of the container
20, into the chamber 19. The medicament is entrained in the
airstream which passes out of the chamber 19 through the grid and
is inhaled by the patient. The first embodiment 10 is a single-use
delivery device and would be discarded after use.
[0047] Turning now to FIGS. 6, 7, 8 and 9, a second embodiment of a
medicament inhaler according to the invention is generally
designated 50. The second embodiment 50 is similar to the first
embodiment 10 save that the medicament container 61 and the
enclosure 62 together form a separate component from the inhaler
50.
[0048] The enclosure 62 and the medicament container 61, for use
with the second embodiment of the inhaler 50, are identical to the
enclosure 14 and container 20 of the first embodiment of inhaler
10. The enclosure 62 and container 61, together with a support ring
63, form a medicament package 60, as shown in FIG. 8. The container
61 is closely received with an interference fit, as in the first
embodiment, within the enclosure 62, with the stud 65 of the
container 61 projecting out of the aperture of the enclosure 62.
The support ring 63 comprises an annular plate and a vertically
orientated upper and lower skirt on the inner edge of the annular
plate. The support ring 63 fits closely around, and is bonded to,
the outside of the cylindrical lower section of the enclosure
62.
[0049] The inhaler 50 is similar to the main body 18 of the first
embodiment 10, save that the enclosure 62 is not bonded to the
circular aperture 52 in the upper end of the chamber 56 The
aperture 52 is provided with a peripheral groove 53 and an upper
section of enlarged diameter, such that the support ring 63 of the
medicament package 60 may be snap fitted from above into the groove
53 within the aperture 52. The upper surface of the inhaler 50 is
provided with a rectangular depression 51 which extends from the
aperture 52 and is dimensioned to accommodate the pad of the
patient's thumb.
[0050] In order to load the inhaler 50, the medicament package 60
is snap-fitted, as described above, into the aperture 52, as shown
in FIG. 10. The method of use is thenceforth identical to the
method of use for the first embodiment 10. After use, however, the
patient places their thumb in the depression 51 and exerts an
upward pressure on the support ring 63 of the medicament package
60, thereby releasing the medicament package from the aperture 52.
The inhaler 50 may subsequently be reloaded with another medicament
package 60.
[0051] Turning now to FIGS. 11, 12 and 13, a third embodiment of a
medicament inhaler according to the invention is generally
designated 100. The inhaler 100 comprises a flat plastics
rectangular base 104 heat-sealed to a formed plastics front portion
102, and a removable laminate cover sheet 106 glued to the outer
surface of the front portion 102.
[0052] The front portion 102 defines a circular chamber 110 having
a passageway 112 extending radially from the side wall of the
chamber 110 along the longitudinal axis of the front portion 102.
The passageway 112 has an air inlet 113 at the end of the
passageway 112 remote from, but in fluid communication with, the
chamber 110.
[0053] The base 104 includes a deformable enclosure 105 that
accommodates a medicament container 120 with a close fit. The
medicament container 120 contains a unit dose of medicament and is
similar to the medicament containers 20 and 61 of the first and
second embodiments save that medicament container 120 is generally
cylindrical in form and does not have a stud corresponding to the
studs 22,65 of the first and second embodiments. The deformable
enclosure 105 is formed so as to seal apertures formed in the side
of the container 120 and hold the container 120 in a position
immediately adjacent the chamber 110.
[0054] The circular front wall of the chamber 110 includes an array
of apertures 111. The front wall of the chamber 110 is adapted so
as to be pressed to a patient's lips so that it may act as a
mouthpiece. When cover sheet 106 is attached to the inhaler 100,
prior to use, apertures 111 and air inlet 113 are sealed.
[0055] In order to use the inhaler 100, a patient simply pulls on a
tab portion 107 of the cover sheet 106. The cover sheet 106
consequently peels away from the surface of the front portion 102
to open apertures 111 and air inlet 113. The deformable enclosure
105 is then depressed, and therefore deformed, using finger
pressure so that the medicament container 120 is introduced into
the chamber 110, as shown in FIG. 14. The depth of the chamber 110
is substantially the same as the depth of the container 120 and
this, together with the resilience of the material from which the
base 104 and front portion 102 are formed, results in the container
120 being held stationary within the chamber 110.
[0056] The mouthpiece is then offered up to the patient's lips,
whereupon inhalation through the apertures 111 causes air to be
drawn into air inlet 113, along passageway 112 and into chamber 110
where the unit dose of medicament contained within the medicament
container 120 is entrained by the airstream and inhaled, through
the apertures 111, by the patient.
[0057] Finally, FIG. 15 shows a further embodiment of an inhaler
150 according to the invention. This embodiment 150 is broadly
similar in function to that of FIGS. 6 and 7, in that it comprises
a main body 151 with a removable medicament package comprising a
flexible, dome-shaped enclosure 152 bonded to a rigid support ring
153. The ring 153 is slid beneath retaining formations 154 that are
formed integrally with the main body 151 in order to position the
enclosure 152 above the chamber of the device (not visible). Air
inlets 155 communicate with the chamber in the same manner as for
the previously-described embodiments. This embodiment differs from
those previously-described embodiments in that the outlet 156
through which air, and entrained medicament, is withdrawn from the
device is relatively narrow and is shaped and dimensioned for
insertion into the user's nostril. This embodiment is therefore
suitable for nasal inhalation.
* * * * *